SETAREH NASSERI
<Contributor>
Essential medicine refers to pharmaceuticals that satisfy the priority health care needs of the population. More specifically, it refers to medicine that is lifesaving and/or life prolonging, including but not limited to vaccines and antiretroviral medications used to treat individuals infected with HIV/AIDS. Each year individuals in developing countries die unnecessarily due to lack of access to these medicines.
One of the barriers to access to essential medicine in developing countries is the lack of research and development geared towards the needs of people in those countries. Research surrounding tropical illnesses sometimes lags behind, and even the treatments currently available are becoming less effective due to resistance.
Another major barrier to access to essential medicine in developing countries is patent law. Typically, patent rights afford the holder, mainly pharmaceutical companies, exclusive rights to the production of the drug for 20 years. This creates a monopoly over their production and importation, reducing access due to high costs.
The Agreement on Trade-Related Aspects of Intellectual Property (“TRIPS”) is an international agreement created by the World Trade Organization (“WTO”) that regulates intellectual property internationally. To “play” in the WTO, signatories must sign on to the minimum requirements set out in TRIPS (including patent protection for pharmaceuticals).
Interestingly, Article 31 of TRIPS provides an optional compulsory licensing mechanism, which provides that an individual or a company can use another patent holder’s intellectual property without seeking the holder’s consent and/or pay the patent holder a set of fees for the license. This, however, is subject to certain requirements, which need to be met. For example, the generic copy must be produced mainly for the domestic market and attempts must be made to obtain a voluntary license first from the patent holder. With respect to exclusive domestic use of drugs, the 2001 Doha Declaration changed this requirement such that countries that are unable to manufacture necessary pharmaceuticals are free to obtain cheaper versions elsewhere.
Despite these advances, the situation is not resolved. In order to use the system, exporting countries must change their laws as well. To date, only the European Union, Canada, Norway and India have complied with this scheme. Though compulsory licensing seems to solve the issue, access to the essential medicine issue has not been resolved. HIV/AIDS is prevalent in South Africa, with about 5.7 million South Africans infected as of 2007. Despite this number, the South African government has never issued a compulsory license. This is attributed to the pressure that Western countries place on South Africa to avoid issuing such licenses.
Médecins Sans Frontières (Doctors Without Borders) has developed the “Access Campaign,” and continues to put pressure on various governmental organizations to resolve the aforementioned issues. They also work towards improvement of access to essential medicine through other means, such as medical innovation. For more information visit www.msfaccess.org.
Setareh Nasseri, RN is a 3L and the Co-President of the Health Law Association.